Duns Number:832637081
Device Description: 4.9MM TI LOCKING BOLT 44MM- STERILE
Catalog Number
45944S
Brand Name
NA
Version/Model Number
459.44S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K962047,K970733,K970097
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
9384dbfc-4fbe-497f-83c4-852758202a7b
Public Version Date
June 22, 2020
Public Version Number
5
DI Record Publish Date
September 14, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
| 3 | A medical device with high risk that requires premarket approval | 30 |
| U | Unclassified | 1 |